Actively Recruiting

Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT07532629

Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes

Led by Karolinska Institutet · Updated on 2026-04-16

1000

Participants Needed

3

Research Sites

350 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective observational cohort study investigates the role of the microbiome and metabolome in couples undergoing in vitro fertilization. Biological samples will be collected from both female and male partners, including semen, vaginal, and blood samples, to characterize microbial composition and metabolic profiles. The study aims to examine how these biological profiles are associated with reproductive outcomes such as fertilization, pregnancy, miscarriage, and live birth. Participants will be followed longitudinally, and reproductive and obstetric outcomes will be obtained through linkage with national health registers.

CONDITIONS

Official Title

Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 40 years at enrolment.
  • Men aged between 18 to 56 years at enrolment.
  • Couples planning to undergo IVF treatment at a participating centre.
  • Sufficient understanding of spoken and written Swedish or English to provide informed consent and complete the web-based questionnaire.
Not Eligible

You will not qualify if you...

  • Pregnancy at the time of enrolment (confirmed or suspected).
  • Recent systemic antibiotic use within the past 4 weeks.
  • Active vaginal or genital tract infection at the time of sampling.

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Reproduktionsmottagning Malmö, Skånes universitetssjukhus

Malmö, Sweden

Actively Recruiting

2

Karolinska Universitetssjukhuset

Stockholm, Sweden, 146 32

Actively Recruiting

3

Reproduktionscenter, Akademiska sjukuhset

Uppsala, Sweden

Actively Recruiting

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Research Team

O

Ola Larsson, PhD

CONTACT

H

Hanna Nilsson, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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